(220 days)
The StimQ Peripheral Nerve Stimulator (PNS) System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
The provided text describes the StimQ Peripheral Nerve Stimulator (PNS) System and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study results in the format requested for an AI/ML device.
The document is a 510(k) summary for a medical device (a peripheral nerve stimulator) that does not appear to be an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to older, legally marketed predicate devices through comparisons of technological characteristics, materials, and non-clinical performance testing against established standards.
Therefore, I cannot extract the information required in your prompt's format from this document because it is not applicable. The device described is a hardware medical device, not an AI/ML algorithm.
If you have a document describing an AI/ML powered medical device, I would be happy to analyze it for the requested information.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2016
StimQ LLC Elizabeth Greene Director of Quality Assurance and Regulatory Affairs 901 East Las Olas Boulevard Suite 201 Fort Lauderdale, Florida 33301
Re: K152178
Trade/Device Name: StimQ Peripheral Nerve Stimulator (PNS) System Regulation Number: 21 CFR 882.5870 Regulation Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief) Regulatory Class: Class II Product Code: GZF Dated: March 8, 2016 Received: March 9, 2016
Dear Ms. Greene,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
| William J. Heetderks -A | Digitally signed by William J. Heetderks -A |
|---|---|
| DN: c=US, o=U.S. Government, ou=HHS, | |
| ou=NIH, ou=People, | |
| 0.9.2342.19200300.100.1.1=0010149848, | |
| cn=William J. Heetderks -A | |
| Date: 2016.03.11 15:31:15 -05'00' |
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: StimO Peripheral Nerve Stimulator (PNS) System
Indications For Use:
The StimQ Peripheral Nerve Stimulator (PNS) System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is written in blue, and the "Q" is written in green and is shaped like a magnifying glass. Behind the word "stimQ" are blue concentric circles that look like sound waves.
510(k) Summary
for
StimQ Peripheral Nerve Stimulator (PNS) System
1. Submission Sponsor
| StimQ LLC | |
|---|---|
| 901 East Las Olas Boulevard | |
| Suite 201 | |
| Fort Lauderdale | |
| Florida 33301 | |
| USA | |
| Phone: | 786.475.7228 |
| Fax: | 786.475.7228 |
| Contact: | Elizabeth Greene, Vice President of Quality Assurance and Regulatory Affairs |
2. Date Prepared
July 31, 2015
3. Device Identification
| Trade/Proprietary Name: | StimQ Peripheral Nerve Stimulator (PNS) System |
|---|---|
| Common/Usual Name: | Peripheral Nerve Stimulator |
| Classification Name: | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Classification Regulation: | 882.5870 |
| Product Code: | GZF |
| Device Class: | 2 |
| Classification Panel: | Neurology |
4. Legally Marketed Predicate Device(s)
Stimwave Freedom SCS System FR8A-A1, FR8A-B1, FR4A-A1, FR4A-B1, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, WAA-A012 (K141399) Medtronic Mattrix 3271/3272 Neuromodulation System (K934065) Medtronic Xtrel, Model Number 3425 Receiver (K883780) ANS Renew Neurostimulation System Transmitter, Model 2508, Receiver Model 3408, Antennae Models 1220 and 1230, Lead Models 3143, 3146, 3153, 3156, 3183 and 3186, Extension Models 3382, 3383, 3341, 3342 and 3343 (K000852)
5. Device Description
The StimO LLC (StimO) StimO Peripheral Nerve Stimulator System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an
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Image /page/4/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in a sans-serif font, followed by a green letter "Q" that is shaped like a magnifying glass. Behind the word "stimQ" are three concentric arcs in blue, resembling sound waves or a signal. The overall design is clean and modern, suggesting a focus on research, analysis, or technology.
electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
Freedom-8A and Freedom-4A Stimulator (Receiver Kit)
| Freedom-8AStimulator,Freedom-4AStimulator | A polyurethane (Pellethane 55D) casing with an embedded receiver,flexible circuit board and electrodes (Platinum Iridium 90:10) that isplaced next to peripheral nerves in the extremities and torso. TheFreedom-8A Stimulator has eight (8) electrodes, and the Freedom-4AStimulator has four (4) electrodes. |
|---|---|
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted intothe open central lumen of the stimulator to provide rigidity duringimplantation. Two (2) stylets are provided in the Receiver Kit, onestraight and one bent, each with diameter of 0.25 mm. |
| Needle andCannula | A 16-gauge stainless steel needle that is packaged inserted in thefluorinated ethylene propylene (FEP) Cannula that acts as a conduit forpassage of the Stimulator next to the peripheral nerve. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollowpathway in tissue for the Stimulator to pass through easily. Themanufacturer of the guidewire is Guidewire Technologies. |
StimQ Wearable Antenna Gear (SWAG) Transmitter Kit
| Transmitter | The SWAG Transmitter housing includes the following components: |
|---|---|
| i. | Transmitting (Tx) Antenna - Flexible Dipole Antenna used to transmit microwave energy to the implanted Stimulator; |
| ii. | Microwave Field Stimulator (MFS) – A printed circuit board (PCB) that generates 915 MHz RF power with embedded waveform parameter settings and switches for changing parameter settings as needed by the user; |
| iii. | Switch Membrane - A elastomeric silicon rubber pad that corresponds to switches on the MFS that allows the user to turn the device on/off or increase or decrease power amplitude as well as interpret device power status (On, Off, Charging, Transmitting, and Bluetooth® Connection); |
| iv. | Battery Assembly – A battery and wire assembly coupled with the Wireless Charging Coil Assembly for charging and the MFS for power delivery; |
| v. | Wireless Charging Coil Assembly – Consists of an inductive charging coil and battery that receives energy from the Wireless Battery Charging Pad. The battery charger components on the MFS are used to transfer charge into the 3.7V lithium ion battery by facilitating power transfer and warns the system when battery power is low |
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Image /page/5/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in blue, followed by a green letter "Q" that is stylized to resemble a magnifying glass. Behind the "Q" are concentric blue circles, suggesting sound waves or a signal. The overall design is clean and modern, with a focus on the company name and a visual representation of its purpose.
StimQ Wearable Antenna Gear (SWAG) Transmitter Kit
| Wireless Battery Charging Pad | An off-the-shelf Qi-compliant charging pad (RP-WCN7, RP-WCN12, or RP-WCN13) that uses inductive charging technology to recharge the encased lithium ion battery of the SWAG Transmitter. |
|---|---|
| ------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
StimQ Wearable Antenna Gear (SWAG) Accessory Kit (each packaged separately)
| Upper Arm | A wearable unit, sourced “off-the-shelf,” designed to fit an upper extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
|---|---|
| Lower Arm | A wearable unit, sourced “off-the-shelf,” designed to fit an upper extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
| Torso | A wearable unit, sourced “off-the-shelf,” designed to fit around the torso, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
| Upper Leg | A wearable unit, sourced “off-the-shelf,” designed to fit a lower extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
| Lower Leg | A wearable unit, sourced “off-the-shelf,” designed to fit a lower extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
Freedom-8A and Freedom-4A Trial Lead (Trial Lead Kit)
| Freedom-8A Trial Lead, Freedom-4A Trial Lead | A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed next to peripheral nerves in the extremities and torso. The Freedom-8A Trial Lead has eight (8) electrodes, and the Freedom-4A Trial Lead has four (4) electrodes. |
|---|---|
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. Two (2) stylets are provided in the Trial Lead Kit, one straight and one bent each with a diameter of 0.25 mm. |
| Needle and Cannula | A 16-gauge stainless steel needle that is packaged inserted in the fluorinated ethylene propylene (FEP) Cannula that acts as a conduit for passage of the Stimulator next to the peripheral nerve. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway in tissue for the Stimulator to pass through easily. The manufacturer of the guidewire is Guidewire Technologies. |
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Image /page/6/Picture/0 description: The image shows the logo for StimQ. The logo has the word "stim" in a dark blue font, followed by a green "Q" that is stylized to look like a magnifying glass. Behind the word and the "Q" are three curved lines that are also dark blue. The curved lines are meant to represent radio waves.
6. Indication for Use Statement
The StimO Peripheral Nerve Stimulator (PNS) System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
7. Substantial Equivalence Discussion
The following table compares the StimQ PNS System to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. Stimwave physically measured Medtronic and ANS predicate devices to obtain the values listed in Table 5A.
| Comparator | StimQ PNSSystem | StimwaveFreedomSCS System(K150517) | StimwaveFreedomSCS System(K141399) | MedtronicMattrix3271/3272(K934065) | MedtronicXtrel, ModelNumber3425(K883780) | ANS Renew(K000852) |
|---|---|---|---|---|---|---|
| Product Code | GZF | GZB | GZB | GZB andGZF | GZB | GZB andGZF |
| Regulation No. | 882.5870 | 882.5880 | 882.5880 | 882.5880 &882.5870 | 882.5880 | 882.5880 &882.5870 |
| Regulation Name | Stimulator,PeripheralNerve,Implanted(Pain Relief) | Stimulator,Spinal-Cord,Implanted(Pain Relief) | Stimulator,Spinal-Cord,Implanted(Pain Relief) | Stimulator,Spinal-Cord,Implanted(Pain Relief)Stimulator,PeripheralNerve,Implanted(Pain Relief) | Stimulator,Spinal-Cord,Implanted(Pain Relief) | Stimulator,Spinal-Cord,Implanted(Pain Relief)Stimulator,PeripheralNerve,Implanted(Pain Relief) |
| Intended Use | Stimulationof peripheralnerves forchronic,intractablepain ofperipheralnerve origin | Stimulationof spinal cordfor chronic,intractablepain of trunkand lowerlimbs | Stimulationof spinal cordfor chronic,intractablepain of trunkand lowerlimbs | Stimulationof spinal cordfor chronic,intractablepain of trunkand lowerlimbs; andperipheralnerve origin | Stimulationof spinal cordfor chronic,intractablepain of trunkand lowerlimbs | Stimulationof spinal cordfor chronic,intractablepain of trunkand lowerlimbs; andperipheralnerve origin |
| Implant Site | Peripheralnerves,excludingcraniofacialregion | Epiduralspace, L5 toT5 | Epiduralspace, L5 toT5 | Epiduralspace, L5 toT5;Peripheralnerves,excludingcraniofacialregion | Epiduralspace, L5 toT5 | Epiduralspace, L5 toT5;Peripheralnerves,excludingcraniofacialregion |
| Comparator | StimQ PNSSystem | StimwaveFreedomSCS System(K150517) | StimwaveFreedomSCS System(K141399) | MedtronicMattrix3271/3272(K934065) | MedtronicXtrel, ModelNumber3425(K883780) | ANS Renew(K000852) |
| Environmental | Hospital,Home | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| IntendedClinician | Orthopedic,Neurosurgeon,Anesthesiologist | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Intended User | Layperson | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| ElectrodeMaterial | Platinum-iridium 90:10 | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Stimulator BodyMaterial | Polyurethane2363-55D | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Cable Features | Multi-lumenTube | Multi-lumenTube | Multi-lumenTube | Coiled Wires | Coiled Wires | Braided Wire |
| StimulatorLength | 45 cm | 45 cm | 45 cm | 30 to 110 cm | 30 to 110 cm | 30 and 60 cm |
| Diameter | 1.35 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | 1.37 mm |
| Electrode ArrayLength | 24 mm52 mm | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| No. of Electrodes | 4 or 8 | 4 or 8 | 4 | 4 | 4 | 4 or 8 |
| Electrode Length | 3.0 mm | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| ElectrodeSpacing | 4.0 mm | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| ElectrodeSurface Area | 12.72 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | "Approx. 13mm²" |
| Method ofIntroduction | Percutaneous | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Tissue Contact | Yes | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Sterilization | EthyleneOxide (EO) | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Labeling | Labeled asSterile,Single Use,PrescriptionDevice | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Package | Backer cardand twosterilepouches | BlisterTray/TyvekLid | BlisterTray/TyvekLid | BlisterTray/TyvekLid | BlisterTray/TyvekLid | BlisterTray/TyvekLid |
| Pulse Frequency | 5 to 1500Hertz | 2 to 1500Hertz | 2 to 1500Hertz | 5 to 240Hertz | 5 to 1400Hertz | 10 to 1500Hertz |
| Pulse Width | 50 to 500microseconds | 50 to 500microseconds | 50 to 500microseconds | 50 to 500microseconds | 50 to 1000microseconds | 50 to 500microseconds |
| Current/VoltageRegulated | Current | Current | Current | Voltage | Voltage | Current |
| Output Voltage(300 Ω) | 0 to 4.1 V | 0 to 4.1 V | 0 to 6.3 V | 0 to 7 V | 0 to 5.4 V | 0 to 5.7 V |
| Output Voltage(500 Ω) | 0 to 6.4 V | 0 to 6.4 V | 0 to 7.2 V | 0 to 10.8 V | 0 to 7.1 V | 0 to 7.6 V |
| Output Voltage(800 Ω) | 0 to 7.5 V | 0 to 7.5 V | 0 to 8.0 V | 0 to 11.6 V | 0 to 8.4 V | 0 to 9.6 V |
| Output Current(300 Ω) | 0 to 13.5 mA | 0 to 13.5 mA | 0 to 21 mA | 0 to 23.3 mA | 0 to 18.0 mA | 0 to 19.0 mA |
| Comparator | StimQ PNSSystem | StimwaveFreedomSCS System(K150517) | StimwaveFreedomSCS System(K141399) | MedtronicMattrix3271/3272(K934065) | MedtronicXtrel, ModelNumber3425(K883780) | ANS Renew(K000852) |
| Output Current(500 Ω) | 0 to 12.8 mA | 0 to 12.8 mA | 0 to 15 mA | 0 to 21.6 mA | 0 to 14.2 mA | 0 to 15.2 mA |
| Output Current(800 Ω) | 0 to 9.4 mA | 0 to 9.4 mA | 0 to 10 mA | 0 to 14.5 mA | 0 to 10.5 mA | 0 to 12.0 mA |
| Waveform | ChargeBalanced(delayed)Biphasicasymmetrical | ChargeBalanced(delayed)Biphasicasymmetrical | ChargeBalanced(delayed)Biphasicasymmetrical | ChargeBalancedBiphasicasymmetrical | ChargeBalancedBiphasicasymmetrical | ChargeBalanced(delayed)Biphasicasymmetrical |
| Pulse Shape | DecayingExponential | DecayingExponential | DecayingExponential | DecayingExponential | DecayingExponential | DecayingExponential |
| Average CurrentDensity (300 Ω) | 105.0 mA/cm² | 105.0 mA/cm² | 111.6 mA/cm² | 175.0 mA/cm² | 125.8 mA/cm² | 117.7 mA/cm² |
| Average CurrentDensity (500 Ω) | 95.1 mA/cm² | 95.1 mA/cm² | 96.7 mA/cm² | 151.7 mA/cm² | 101.7 mA/cm² | 103.1 mA/cm² |
| Average CurrentDensity (800 Ω) | 69.0 mA/cm² | 69.0 mA/cm² | 77.0 mA/cm² | 106.7 mA/cm² | 75.8 mA/cm² | 86.2 mA/cm² |
| Maximum PhaseCharge* (300 Ω) | 6.8 µC/pulse | 6.8 µC/pulse | 10.5 µC/pulse | 11.7 µC/pulse | 18.0 µC/pulse | 9.5 µC/pulse |
| Maximum PhaseCharge* (500 Ω) | 6.4 µC/pulse | 6.4 µC/pulse | 7.2 µC/pulse | 10.8 µC/pulse | 14.2 µC/pulse | 7.6 µC/pulse |
| Maximum PhaseCharge* (800 Ω) | 4.7 µC/pulse | 4.7 µC/pulse | 5.0 µC/pulse | 7.3 µC/pulse | 10.5 µC/pulse | 6.0 µC/pulse |
| Maximum ChargeDensity* (300 Ω) | 53.1 µC/cm² | 53.1 µC/cm² | 82.5 µC/cm² | 97.2 µC/cm² | 150.0 µC/cm² | 73.1 µC/cm² |
| Maximum ChargeDensity* (500 Ω) | 50.3 µC/cm² | 50.3 µC/cm² | 56.6 µC/cm² | 90.0 µC/cm² | 118.3 µC/cm² | 58.5 µC/cm² |
| Maximum ChargeDensity* (800 Ω) | 36.9 µC/cm² | 36.9 µC/cm² | 39.3 µC/cm² | 60.4 µC/cm² | 87.5 µC/cm² | 46.2 µC/cm² |
| MaximumCurrent Density*(300 Ω) | 106.1 mA/cm² | 106.1 mA/cm² | 165.1 mA/cm² | 194.4 mA/cm² | 150.0 mA/cm² | 146.2 mA/cm² |
| MaximumCurrent Density*(500 Ω) | 100.6 mA/cm² | 100.6 mA/cm² | 113.2 mA/cm² | 180.0 mA/cm² | 118.3 mA/cm² | 116.9 mA/cm² |
| MaximumCurrent Density*(800 Ω) | 73.9 mA/cm² | 73.9 mA/cm² | 78.6 mA/cm² | 120.8 mA/cm² | 87.5 mA/cm² | 92.3 mA/cm² |
| Net Charge | 0 µC | 0 µC | 0 µC | 0 µC | 0 µC | 0 µC |
| Average PhasePower (300 Ω) | 0.053 W/phase | 0.053 W/phase | 0.060 W/phase | 0.132 W/phase | 0.068 W/phase | 0.070 W/phase |
| Average PhasePower (500 Ω) | 0.073 W/phase | 0.073 W/phase | 0.076 W/phase | 0.166 W/phase | 0.074 W/phase | 0.090 W/phase |
| Average PhasePower (800 Ω) | 0.062 W/phase | 0.062 W/phase | 0.060 W/phase | 0.131 W/phase | 0.066 W/phase | 0.100 W/phase |
| Average PhasePower Density(300 Ω) | 0.42 W/cm²/phase | 0.42 W/cm²/phase | 0.48 W/cm²/phase | 1.10 W/cm²/phase | 0.57 W/cm²/phase | 0.54 W/cm²/phase |
| Average PhasePower Density(500 Ω) | 0.58 W/cm²/phase | 0.58 W/cm²/phase | 0.59 W/cm²/phase | 1.38 W/cm²/phase | 0.62 W/cm²/phase | 0.69 W/cm²/phase |
| Average PhasePower Density(800 Ω) | 0.48 W/cm²/phase | 0.48 W/cm²/phase | 0.60 W/cm²/phase | 1.09 W/cm²/phase | 0.55 W/cm²/phase | 0.77 W/cm²/phase |
| Comparator | StimQ PNSSystem | StimwaveFreedomSCS System(K150517) | StimwaveFreedomSCS System(K141399) | MedtronicMattrix3271/3272(K934065) | MedtronicXtrel, ModelNumber3425(K883780) | ANS Renew(K000852) |
| Pulse DeliveryMode | Continuous | Continuous | Continuous | Continuous | Continuous | Continuous |
| ON/OFF Times | No Cycling | No Cycling | No Cycling | ON/OFFCyclingOption | ON/OFFCyclingOption | No Cycling |
| Current PathOptions | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar |
| Power Delivery | Coupledreceiver builtinto Stimulatorbody | Same asStimQ | Same asStimQ | Coupledreceiver,hardwiredconnector | Coupledreceiver,hardwiredconnector | Coupledreceiver,hardwiredconnector |
| TransmitFrequency | 915 MHz | 915 MHz | 915 MHz | 2 MHz | 1.60 MHz | 2 MHz |
| Material | Platinum-iridium90:10,Polyurethane2363-55D | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Sterile | Yes -ethyleneoxide | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ | Same asStimQ |
| Single-Use | Yes | Yes | Yes | Yes | Yes | Yes |
| Shelf Life | 2 year | 2 year | 1 year | 1 year | 1 year | 2 years |
| Complies withISO 10993-1 | Yes | Yes | Yes | Yes | Yes | Yes |
| Safety TestingPassed | Yes | Yes | Yes | Yes | Yes | Yes |
Table 5A. Comparison of Characteristics
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Image /page/7/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is written in a dark blue sans-serif font. The "Q" is green and stylized to look like a magnifying glass. Behind the word is a series of curved lines that resemble radio waves, also in dark blue.
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Image /page/8/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is in blue, and the "Q" is in green. To the right of the word is a graphic of concentric blue circles, which appear to be emanating from the "Q".
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Image /page/9/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in dark blue, followed by a green letter "Q" that is shaped like a magnifying glass. Behind the word and the "Q" are three curved lines in dark blue, resembling sound waves or radio waves emanating from the "Q".
(*) asterisk denotes that formulas were used for the calculations.
8. Biocompatibility Data
The StimO PNS System uses the same stimulator as the Stimwave Freedom SCS System. Thus, the materials of the StimQ PNS System remain unchanged from the Freedom SCS System (K150517 and K141399). The biocompatibility tests conducted on representative subassemblies of the Freedom SCS System (Freedom-4, K141399) directly apply to the StimQ PNS System. The materials, construction and intended use of the StimQ PNS System is comparable to the predicate device, and have a long history of safety with respect to biocompatibility. The biological safety of the Stimulator was evaluated in accordance to ISO 10993-1:2009 and guidance document Blue Book Memorandum G95-1 Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a (C), implant device in contact with tissue/bone. The results for the biocompatible testing for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, and 13 weeks), and subchronic toxicity demonstrated no negative impacts from the materials that are used in the StimQ PNS System. The Freedom-8A/4A Stimulator materials in direct tissue contact include Pellethane 55D and Pt-Ir (90:10), both having an extensive record (previously cleared and approved) of chronic and carcinogenetic safety. The SWAG is intended to be
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Image /page/10/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in blue, followed by a green letter "Q" that is stylized to resemble a magnifying glass. Behind the "Q" are three curved blue lines that emanate outward, suggesting sound waves or a signal. The overall design is clean and modern, using a combination of text and graphic elements to represent the brand.
on top of an article of clothing. The User Manual provided to the patient describes that the SWAG should always be worn on top of a layer of clothing. The SWAG does not come into contact with the patient's skin. The categorization by nature of body contact of the SWAG is thus "non-contacting device", and not included in the scope of ISO 10993-1:2009. The StimQ PNS System (similar in form to the Freedom SCS System, K141399 and K150517) meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1.
9. Non-Clinical Performance Data
The StimQ PNS System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The StimQ PNS System complies with all design requirements and applicable voluntary standards.
AAMI ANSI ISO 14708-3:2008 - For protection from temperature change including shipping and storage temperature ranges, the StimQ Stimulator was functional, receiving a safe rating following post visual inspection and passed the change of temperature testing performed as specified by AAMI ANSI ISO 14708-3:2008. For atmospheric pressure change, the StimO Stimulator was functional following post testing functionality inspection and passed atmospheric pressure change testing as specified by AAMI ANSI ISO 14708-3:2008.
For testing external defibrillation exposure, the StimQ Stimulator was verified as functional after exposure to external defibrillation. Thus, the StimQ Stimulator complies with testing as specified by AAMI ANSI ISO 14708-3:2008.
Following the thermal shock testing, the StimQ Stimulator was found to have "no irreversible damage" and fully functional as specified by the manufacturer, and to have no physical anomalies present at the time of inspection. Thus, the StimQ Stimulator complies with the thermal shock design requirements and the applicable standard.
For leakage current testing, the StimQ Stimulator produced zero leakage current on all tested paths for all tested samples. Thus, the StimQ Stimulator complies with the leakage design requirements and the applicable standard.
For testing the insertion and withdrawal of the stimulator within the stylet, the StimQ Stimulator was found to require less than 2.5N of insertion or withdrawal force for all tested stylets in all tested stimulator samples. Visual inspection confirmed no damage was present in any stimulator samples. Thus, the StimO Stimulator complies with design specifications for stylet insertion and withdrawal force.
For mechanical testing, the StimQ Stimulator passed all criteria of the test, showing no visible damage to the stimulator body or functional damage to the components. Mechanical testing included tensile testing, flex testing and torsion testing. Thus, the StimO Stimulator complies with all stimulator mechanical design requirements.
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Image /page/11/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in blue, followed by a green letter "Q" that is shaped like a magnifying glass. Behind the word and letter is a series of blue concentric arcs, resembling sound waves or radio waves. The logo is simple and modern, using a combination of text and graphic elements to represent the company.
IEC 60601-1 - For testing the external unit for protection from temperature change, including shipping and storage temperature ranges, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the external unit of the StimO PNS System satisfies the outlined protection from temperature change design requirements and the applicable standard, IEC 60601-1. For atmospheric pressure change testing, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the external unit of the StimO PNS System satisfies the outlined atmospheric pressure change design requirements and the applicable standard, IEC 60601-1. For the push, drop, and impact testing of the external unit, it was determined through testing that the external unit is robust to withstand expected damage in accordance with general safety standards. The external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the SWAG component of the StimQ PNS System satisfies the outlined push, drop, and impact, design requirements and the applicable standard, IEC 60601-1. For the identification, marking and documents of the external unit it was determined through an analysis of the labeling that the external unit complies with the requirements of the standard. All requirements and markings are clearly identified and viewable either from the external case of the product or from within the accompanying documents. For the means of protection, creepage distances, and air clearances of the external unit it was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1.
IEC 60529 - For testing the ingress of water, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the SWAG component of the StimQ PNS System satisfies the outlined Ingress of Water design requirements and the applicable standard IEC 60529. For particulate matter testing, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the SWAG component of the StimQ PNS System satisfies the outlined Particulate Matter design requirements and the applicable standard, IEC 60529.
IEC 60601-1-2 - For testing the external unit for electromagnetic compatibility, the unit met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, radiated RF electromagnetic fields, electrical fast transients and bursts, and magnetic fields. For testing the external unit for electrostatic discharge, the unit met all acceptance criteria for exposure to contact discharge testing from discharge levels per IEC 60101-1-2. During air discharge testing, observations were noted for exposure to discharge levels of ±8 kV and ±15 kV. The noted observations are acceptable, the device remains safe; the StimO PNS System is in compliance with IEC 60601-1-2 $5.2.2.1(e). The external unit operated within all test limits and showed no physical damage and was fully operational. Thus, the external unit for the StimO PNS System satisfies the IEC 60601-1-2 standard.
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Image /page/12/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in a dark blue sans-serif font, followed by a green "Q" that is stylized to resemble a magnifying glass. To the right of the "Q" are three concentric arcs in dark blue, suggesting a signal or wave emanating from the magnifying glass. The overall design is clean and modern, conveying a sense of investigation or stimulation.
The StimQ PNS System complies with the applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, packaging, and sterilization. The software of the StimO PNS System passed all verification tests outlined and the design requirements for Software Verification have been met. The device passed all the testing in accordance with national and international standards.
Following performance testing, it has been determined that the StimQ PNS System is substantially equivalent to legally marketed predicate devices for the therapy for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain.
StimO LLC completed a number of tests for the StimO PNS System that demonstrates substantial equivalence to the legally marketed predicate devices. The StimQ PNS System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The StimQ PNS System passed all testing stated above as shown by the acceptable results obtained.
10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use are equivalent to the legally marketed predicate device. These types of devices, including the legally marketed predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to legally marketed predicate devices when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The StimQ PNS System has the same intended use as the legally marketed predicates devices and is implanted percutaneous next to the peripheral nerves of the torso and extremities. Performance tested verified that the StimO PNS System complies with all applicable voluntary standards such as IEC 60601-1, AAMI ANSI ISO 14708-3, and IEC 60529. The StimQ PNS System also meets the design requirements where no applicable standard could be used. This included stimulator body durability testing, programmable parameters, as well as power and performance of the external unit. There were no recognized performance standards for this device. There was no clinical testing performed on this device since performance testing demonstrated similar performance as the legally marketed predicate devices, and materials for the implanted stimulator are the same as the legally marketed predicate devices.
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Image /page/13/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in blue, followed by a green letter "Q" that is stylized to look like a sound wave. The sound wave is made up of three concentric arcs in blue, emanating from the right side of the "Q". The logo is simple and modern, and the use of blue and green gives it a clean and professional look.
It has been shown in this 510(k) submission that the difference between the StimQ PNS System and the legally marketed predicate devices do not raise any questions regarding its safety and effectiveness as compared to legally marketed predicate devices. StimQ PNS System, as designed and manufactured, is determined to be substantially equivalent to the referenced legally marketed predicate devices.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).